FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115393–115416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1992
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
K924854 · JJX
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
K924855 · JJX
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
K924863 · JJX
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K924965 · CFJ
Olympus Corp.
Chemistry · 47d
Cleared Nov 13, 1992
ALCON(R) FX2(TM) PHOTOCOAGULATOR
K914334 · GEX
Alcon Laboratories
General & Plastic Surgery · 413d
Cleared Nov 10, 1992
MALECOT-NEPHROSTOMY TAMPONADE CATHETER
K915209 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 358d
Cleared Nov 10, 1992
MORTARA INSTRUMENT ODEL ELI 50I
K915730 · LOS
Mortara Instrument, Inc.
Cardiovascular · 326d
Cleared Nov 10, 1992
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
K920002 · CBK
Puritan Bennett Corp.
Anesthesiology · 313d
Cleared Nov 10, 1992
INMAN MEDICAL PETROLATUM DRESSING
K921289 · FRO
Inman Medical Corp.
General & Plastic Surgery · 244d
Cleared Nov 10, 1992
INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT
K921845 · DQO
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 207d
Cleared Nov 10, 1992
MRT-35(TM)
K921940 · LNH
Toshiba America Mri, Inc.
Radiology · 200d
Cleared Nov 10, 1992
STATPAL II BLOOD GAS ANALYSIS SYSTEM
K922631 · CHL
Ppg Industries, Inc.
Chemistry · 160d
Cleared Nov 10, 1992
MORTARA INSTRUMENT ST CENTRAL STATION
K922927 · DPS
Mortara Instrument, Inc.
Cardiovascular · 146d
Cleared Nov 10, 1992
SHORT TEGWIRE -- MODIFIED
K924276 · LIT
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 09, 1992
BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM
K911518 · DRX
Lead-Lok, Inc.
Cardiovascular · 585d
Cleared Nov 09, 1992
BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG
K911529 · DRX
Lead-Lok, Inc.
Cardiovascular · 585d
Cleared Nov 09, 1992
SONICATH(TM) 3.5 F, 20 MHZ
K913890 · ITX
Boston Scientific Corp
Radiology · 438d
Cleared Nov 09, 1992
DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250
K915647 · ITX
Pie Medical Equipment B.V.
Radiology · 327d
Cleared Nov 09, 1992
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND
K921044 · DYH
Wallace A. Erickson & Co.
Dental · 250d
Cleared Nov 09, 1992
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194 · DRT
Hewlett-Packard Co.
Cardiovascular · 242d
Cleared Nov 09, 1992
SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT
K921941 · LNH
General Electric Co.
Radiology · 199d
Cleared Nov 09, 1992
HEMO-STAT
K922636 · SEJ
Mckinley-Ross Laboratories, Inc.
General & Plastic Surgery · 164d
Cleared Nov 09, 1992
DU PONT LINX HD-25 LASR IMAGER
K923042 · LLZ
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 138d
Cleared Nov 09, 1992
JT-1 POWERED TRACTION UNIT
K923103 · ITH
Chirotronics, Inc.
Physical Medicine · 137d